The Effect of Gabapentin Used as a Preemptive to the Emergence and Development Chronic Neuropathic Pain in Patients After Spinal Cord Trauma

• Status: Withdrawn
• Trial end date: 2020-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Study of the effect of gabapentin used as a preemptive to the emergence and development chronic neuropathic pain in patients after spinal cord trauma

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Masaryk University
• Treatments: Dipyrone; Gabapentin; Tramadol

Criteria

Inclusion Criteria:

1. Men and women, age 18 - 65 years

2. Signed written informed consent

3. Patients after complete/non-complete spinal lesion, after surgery

4. Patients with spinal cord trauma caused mechanically demanding (due a injury of a bone fragment, a disk, a translation spinal canal)

5. Patient willing and able to comply with the study protocol

6. Male and females with a highly effective method of birth control plus an additional barrier method

Exclusion Criteria:

1. Patients with spinal cord lesion ischemic etiology

2. Pregnant women, nursing or childbearing age with a positive pregnancy test input

3. Patients unable or unwilling to comply with the study protocol

4. Acute pancreatitis in 1 year from the start of the study

5. Chronic pancreatitis in the case history

6. Active or uncontrolled infectious diseases

7. Hypersensitivity to any component of the investigational product

8. Active autoimmune disease

9. Serious neurological disease with the incidence chronic neuropathic pain